Study of Haemodialysis Patients Switching From Aranesp to Biosimilar

Anaemia Clinical Trial

— SHADE  

Official title:

Retrospective Study of Stable Haemodialysis Patients Switched From Darbepoetin Alfa to Epoetin Alfa Biosimilar

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191150
• Other study ID #: 20130300
• Status: Completed
• Phase: N/A
• First received: July 7, 2014
• Last updated: February 5, 2016
• Start date: June 2014
• Est. completion date: May 2015

Study information

• Verified date: February 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Each site's local Ethics CommitteeItaly: Local Ethics CommitteesItaly: RSO (Register of Observational Studies)Italy: AIFABulgaria: Bulgarian Drug AgencyBulgaria: Ethics Committee for Multicenter Trials (ECMT)Spain: Agencia Española de Medicamentos y Productos SanitariosPoland: Not applicableAustralia: Princess Alexander Hospital Ethics Committee
• Study type: Observational

Clinical Trial Summary

The study will obtain data to show insight into clinical outcomes of patients switching from Darbepoetin Alfa to a epoetin alfa biosimilar.

Description:

Biosimilars were approved in 2007 by the EMA in EU and in 2010 by the TGA in Australia. This study will look at the retrospective data of patients that have switched from Darbepoetin Alfa to an approved epoetin alfa biosimilar. Data will be collected for the 26 week period prior to switch and a 26 week period post switch to a biosimilar. Data to be collected includes haemoglobin measurements, dose requirements, iron use, any transfusions, hospitalisations and other lab values including TSAT, Ferritin and albumin. Data from the study will be published.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Patients =18 years of age

• Patients with CKD on haemodialysis and fulfilling the following:

• Received HD for at least 26 weeks prior to switching from treatment with darbepoetin alfa to treatment with an EMA/TGA-approved epoetin alfa biosimilar

• Received darbepoetin alfa treatment i.v. for at least 26 weeks immediately prior to switching to an EMA/TGA-approved epoetin alfa biosimilar (breaks due to treatment being intentionally withheld are permitted)

• Switched from darbepoetin alfa treatment to an EMA/TGA-approved epoetin alfa biosimilar at least 26 weeks prior to enrolment

• Received at least one dose of an EMA/TGA-approved epoetin alfa biosimilar after switching from darbepoetin alfa treatment

• Mean monthly Hb 10-12g/dL in the 12 weeks prior to switch

• Stable darbepoetin alfa dose (i.e. no more than one increment or decrement of PFS) in the 12 weeks prior to switch

• Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements

Exclusion Criteria:

• Treatment with an ESA other than darbepoetin alfa during the 12 weeks prior to switch to biosimilar

• More than 14 days' cumulative treatment with short-acting ESA during weeks 26-13 prior to switch to biosimilar

• Subject received chemotherapy or major surgery during the 26 weeks prior to switch to biosimilar

• Subject was enrolled in an interventional device or drug study at any time during the 52-week data observation period or within 30 days prior to commencement of the data observation period.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anaemia

Locations

Country	Name	City	State
Australia	Research Site	Herston	Queensland
Australia	Research Site	Nambour	Queensland
Australia	Research Site	Woolloongabba	Queensland
Bulgaria	Research Site	Burgas
Germany	Research Site	Lemgo
Germany	Research Site	Lich
Germany	Research Site	Minden
Greece	Research Site	Egaleo
Greece	Research Site	Egaleo, Athens
Greece	Research Site	Kallithea, Athens
Greece	Research Site	Larissa
Greece	Research Site	Patra
Greece	Research Site	Patra
Italy	Research Site	Milazzo ME
Italy	Research Site	Pisa
Poland	Research Site	Chojnice
Poland	Research Site	Gdansk
Poland	Research Site	Krakow
Poland	Research Site	Lublin
Poland	Research Site	Poznan
Poland	Research Site	Rybnik
Spain	Research Site	Jaen	Andalucía
Spain	Research Site	Zamora	Castilla León

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Australia,  Bulgaria,  Germany,  Greece,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Subjects with PRCA testing and incidence of neutralizing anti-erythropoietin antibodies	Pure Red Cell Aplasia (PRCA) test and results	Duration of 52-week observation period	Yes
Primary	Haemoglobin Concentration	Mean haemoglobin concentration over time	Duration of observation period -52 weeks	No
Secondary	ESA Doses	Doses of ESA over time.	Duration of observation period -52 weeks	No
Secondary	Dose ratio	Dose ratio between the start of the post-switch observation period and pre-switch	Start post-switch (weeks 1-4) and pre-switch (weeks -4--1)	No
Secondary	Dose ratio	Dose ratio between the end of the post-switch observation period and pre-switch	Between end of post-switch (weeks 23-26) and pre-switch (weeks -4--1)	No
Secondary	Haemoglobin excursions	Haemoglobin excursions (<10/dL and >12g/dL)	Duration of observation period -52 weeks	No
Secondary	Haemglobin within range	Haemoglobin in the range 10-12g/dL over time	Duration of observation period -52 weeks	No
Secondary	TSAT, ferritin and albumin values	TSAT, ferritin and albumin over time	Duration of observation period -52 weeks	No
Secondary	Iron Use	Iron use (dose/route) over time	Duration of observation period -52 weeks	No
Secondary	Red cell transfusions (including number of units transfused)	Red cell transfusions (including number of units transfused)	Duration of observation period -52 weeks	No
Secondary	Hospitalisations (including primary cause)	Hospitalisations (including primary cause)	Duration of observation period -52 weeks	No

External Links

•   AmgenTrials clinical trials website